Biosimilars of adalimumab: the upcoming challenge in IBD

ABSTRACT

Introduction: Biosimilars represent great potential in cost saving and re-investment opportunities in healthcare and allow patients greater access to effective mAbs. Infliximab biosimilars are successfully used in all indications for whom the reference product (RP) was approved.

Areas covered: In late 2018, adalimumab biosimilars will also be available in patients with inflammatory bowel disease (IBD).

ABP501, BI 695501, GP2017, and SB5 have been approved by the EMA for the same indications of the reference product (RP, Humira®). Preclinical data show high similarity between all biosimilars and the RP. Clinical data in patients with rheumatoid arthritis and psoriasis also show no differences in terms of efficacy, safety, and immunogenicity. Data in IBD patients are still lacking.

Expert opinion: Biosimilars of adalimumab appear to be clinically equivalent to the RP. Decisions based on choosing the ideal patient to receive or to be switched to a biosimilar of adalimumab, or choosing one biosimilar vs. another, or cross-switching among biosimilars remain the next challenge in the field of IBD.

KEYWORDS:

• Adalimumab
• biosimilar
• Crohn’s disease
• inflammatory bowel disease
• ulcerative colitis

Article highlights

• Biosimilars represent a great opportunity to treat patients with efficacious therapies at significantly lower costs

• Biosimilars of adalimumab will be available for all indications of the reference product

• Preclinical data of all the biosimilars approved by EMA show high similarity to the reference product

• Clinical data in the most sensitive indications (RA and Pso) show no significant differences in terms of efficacy, safety and immunogenicity as compared to the reference product

• Choosing the ideal patient to receive or to be switched to a biosimilar of adalimumab, choosing one biosimilar vs. another, or cross-switching among biosimilars remain the next challenge in the field of IMID, including IBD.

This box summarizes key points contained in the article.

Declaration of interest

G Fiorino served as a consultant and a member of Advisory Boards for MSD, Takeda Pharmaceuticals, AbbVie, Pfizer, Celltrion, Amgen, Sandoz, Samsung, and Janssen Pharmaceuticals; M Allocca received consulting fees from Nikkiso Europe and lecture fees from Janssen and Pfizer; L Peyrin-Biroulet served as a consultant for Merck, Abbvie, Janssen, Ferring, Tillots, Celltrion, Takeda, Pfizer, Amgen, Biogen, Samsung Bioepis, Genentech, Vifor, Pharmacosmos, Biogaran, Boerhinger-Ingelheim, Lilly, Index Pharmaceuticals, Sandoz, Celgene, Alma, Sterna, Nestlé, Enterome; S Danese served as a consultant and a member of Advisory Boards for Abbvie, Ferring, Hospira, Johnson & Johnson, Merck, Millennium Takeda, Mundipharma, Pfizer, Tigenix, UCB Pharma, and Vifor. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper is not funded.